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1. 01

   Audit need

   Subject and purpose

   What needs to be audited?*

   Self-inspectionSupplier auditCMO auditContracted laboratoryOther

   Why is the audit being done?*

   First audit or qualificationRoutine oversightPeriodic requalificationFor cause or risk-triggeredCAPA follow-up or re-audit

   What does the site make or handle?*It decides which requirements apply and how much of the audit is spent on the floor.

   Dried flower or biomassExtracts, resins or oilsActive substance (API)Finished medicinal productPrimary or secondary packagingAnalytical testingStorage, transport or distributionNot decided yet

   How many sites

   Total sites or entitiesIt fills itself from the countries in the next step. Change it if that is not right.

   History and certificates

   What already exists for this site?Anything here shortens the pre-audit review. A site with a history is sampled against what is known; a site without one is covered in full. We ask for the documents themselves once an NDA is in place.

   Never auditedYou have audited it beforeAudited by another customer or a third partyInspected by a national authorityEU GMP certificateNational manufacturing licenceGACP certificateGDP or wholesale licenceNarcotics or controlled-substance licenceA completed supplier questionnaireA quality or technical agreementFindings still open from a previous auditNone of theseNot sure

   Fields marked * are the ones we cannot quote without.

   Continue to sites
2. 02Sites and countriesWhere the sites are, how big they are and how to get in
3. 03Scope and timingRequirements, coverage, dates and what the report has to do
4. 04Contact detailsWho you are and how we reach you

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